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Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2009
First Received: February 27, 2008   Last Updated: November 16, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Pfizer
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00631527
  Purpose

The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Leuprolide
Drug: Goserelin
Drug: Sunitinib Malate
Drug: Casodex
Radiation: Radiation Therapy (RT)
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT) [ Time Frame: 8 week period of combined hormone ablation, Sunitinib, and radiation therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: February 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sunitinib Malate, Hormone Ablation + RT: Experimental
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
Drug: Leuprolide
Injections given through a needle in the muscle every 3 months.
Drug: Goserelin
Subcutaneous injections given once every 3 months.
Drug: Sunitinib Malate
Starting dose of 12.5 mg by mouth daily for 4 weeks
Drug: Casodex
Once a day by mouth for 2 weeks.
Radiation: Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.
  2. Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
  3. ECOG Performance Status 0-1
  4. Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x UNL, Total bilirubin WNL.
  5. No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
  6. Patients must be at least 18 years of age
  7. Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.

Exclusion Criteria:

  1. Prior VEGFR/PDGFR inhibitor or other investigational therapy.
  2. Inability to take oral medication
  3. Uncontrolled hypertension (blood pressure > 140/90 mm Hg despite optimal medical therapy), Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
  4. Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631527

Contacts
Contact: Paul Corn, MD, PHD 713-792-2830

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Principal Investigator: Paul Corn, MD, PHD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Paul Corn, MD, PHD/Assistant Professor )
Study ID Numbers: 2006-0684
Study First Received: February 27, 2008
Last Updated: November 16, 2009
ClinicalTrials.gov Identifier: NCT00631527     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Radiation Therapy
Radiotherapy
Hormone Ablation
Sunitinib Malate
SU011248
Sutent
Prostate Cancer
RT
Leuprolide
Lupron
Zoladex
Goserelin
Casodex
Bicalutamide
Angiogenesis inhibitor

Additional relevant MeSH terms:
Sunitinib
Antineoplastic Agents, Hormonal
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Reproductive Control Agents
Neoplasms by Site
Leuprolide
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Goserelin
Genital Diseases, Male
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Fertility Agents, Female
Fertility Agents
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010